Susan Sangster

Current

• Director Regulatory Affairs Europe at Medpace Switzerland GmbH

Past

• Vice President of Regulatory Affairs at Merck Serono International SA
• Vice President Corporate Regulatory Affairs at Merck Serono International SA previously Serono international SA
• Worldwide Director Regulatory affairs -Neurology at Merck Serono International SA previously Serono International SA

• Executive Director Regulatory Affairs at Covance
• Executive Director Regulatory Affairs Europe at Covance CAPS Ltd
• Director Regulatory Affairs Europe at Covance CAPS Ltd
• Associate Director of Regultory Affairs Europe at Covance
• Group Manager Regulatory Affairs at Marion Merrell Dow Research Institute
• Regulatory Specialist at Marion Merrell Dow Research Institute
• Regulatory Scientist at Marion Merrell Dow Research Institute
• Product Registration Manager at Tate & Lyle
• Post Doctoral Research Fellow at St Mary's Hospital Medical School
• Post Graduate Student at St Mary's Hospital Medical School
• Research Biochemist at Wyeth Research

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Education

• University of London
• University of Surrey

Connections

107 connections

Industry

Pharmaceuticals

Susan Sangster’s Summary

Successful Global Regulatory Affairs Professional with over 20 years' experience. Experienced leader in Pharmaceutical Development: both biotechnology and chemical products. Driver of regulatory strategies throughout development to successful authorisations in all ICH regions and ROW. Successfully managed large teams of regulatory professionals. Developed and managed a large profitable global regulatory consultancy business. Member of Pharmacuetical Trade and Professional Committees. Fellow of TOPRA.

Susan Sangster’s Specialties:

Global regulatory strategies, throughout development and maximising revenues in the product life cycle.
Managing large professional teams
Managing a profitable regulatory consultancy business

Susan Sangster’s Experience

• Director Regulatory Affairs Europe

  Medpace Switzerland GmbH

  (Privately Held; Pharmaceuticals industry)

  August 2009 — Present (4 months)

  Responsible for developing and directing regulatory affairs business in Europe.

• Vice President of Regulatory Affairs

  Merck Serono International SA

  (Privately Held; Pharmaceuticals industry)

  May 2007 — July 2009 (2 years 3 months)

  This role involved management of the Ant-iiflamamtory, Immunology Dermatology and Emerging Therapies (AIID&ET), Therapeutica Area, European Coordination, Global Regulatory Intelligence and the Manufacturing regulatory Affairs Team. The responsibilities provision of quality modules for global submissions. provision of regulatory strategy ,submissions authorisations for all AIID&ET products in ICH regions. Effective global regulatory intelligence, co-ordination of the European affliates. Representation on behalf of Merck Serono at Trade and Professional Committees.

• Vice President Corporate Regulatory Affairs

  Merck Serono International SA previously Serono international SA

  (Pharmaceuticals industry)

  September 2002 — May 2007 (4 years 9 months)

  Responsible for the management of the Corporate Regulatory Affairs function (50 staff), providing international (European, US, Japan and ROW) regulatory expertise for global product development, core regulatory documentation (quality,safety and efficacy) for use worldwide in supporting successful regulatory registrations. The function consisted of a Manufacturing Regulatory Affairs Team, four Therapeutic Area Teams, Regulatory Operations and Regulatory Intelligence.
  Reponsible for providing strategic regulatory advice at the highest level in the company, on the senior supervisory product development and research committees. Responsible for effective regulatory intelligence. providing support to the Business Development function for in-licensing opportunities. Responsible for ensuring provision of expertise and systems to update and maintain regulatory operations systems and training worldwide. Representation on behalf of Serono on Trade and Professional committees.

• Worldwide Director Regulatory affairs -Neurology

  Merck Serono International SA previously Serono International SA

  (Pharmaceuticals industry)

  March 2001 — September 2002 (1 year 7 months)

  Responsible for the coordination of global regulatory strategies for all Neurology products. Including preparation of the core documentation and support of the regulatory process through to authorisation and life cycle management activities; to maintain and prolong the profitability of the products.

• Executive Director Regulatory Affairs

  Covance

  (Public Company; CVD; Pharmaceuticals industry)

  October 1999 — March 2001 (1 year 6 months)

  Responsible for the profitabilty of the Global Regulatory Business Centre involving over 60 professional regulatory staff worldwide. Provision of global direction reponsible for the review and approval of all activities related to submission documentation, regulatory affairs strtegies and regulatory consultancy. Responsible for the management of all contracts for regulatory business. Provided global regulatory consultancy. Experience covered a wide variety of products from early development to life cycle management, and across many indications and involving many presentations and formulations.

• Executive Director Regulatory Affairs Europe

  Covance CAPS Ltd

  (Pharmaceuticals industry)

  March 1999 — October 1999 (8 months)

  Head of the Regulatory Documentation Business Centre in Europe( developed to approx 30 staff), including responsibility for regulatory submissions, regulatory consultancy, medical writing health economics. Responsibility for business development and profitability.

• Director Regulatory Affairs Europe

  Covance CAPS Ltd

  (Pharmaceuticals industry)

  March 1996 — March 1999 (3 years 1 month)

  Head of Regulatory Documentation and Safety Business Unit in Europe. Developed the profitable safety business from 3 to over 25 staff. Regulatory documentation team reponsible for management of regulatory submissions and strategy ,medical writing including CSRs and marketing application documents.

• Associate Director of Regultory Affairs Europe

  Covance

  (Public Company; CVD; Pharmaceuticals industry)

  April 1995 — March 1996 (1 year )

  Responsible for the regulatory and Drug Safety support for the core clinical business. Also to develop standalone regulatory business. Responsible for regulatory strategies and submissions for assigned projects and adverse event reporting for Europe

• Group Manager Regulatory Affairs

  Marion Merrell Dow Research Institute

  (Pharmaceuticals industry)

  June 1991 — 1995 (4 years )

  This role management of a team of Regukltory professionals. Reponsibility for European strategy and submissions for global products. Recommendationd on data requirements and regulatory strategies for early clinical candidates and in-licensing opportunities. Development of submissions using elecronic media. Safety reporting in Europe for clinical trials. Mangementof submission stertegies for export markets, Eastern Europe, Middle East and Africa.

• Regulatory Specialist

  Marion Merrell Dow Research Institute

  (Pharmaceuticals industry)

  June 1989 — June 1991 (2 years 1 month)

  Management of a team with responsibility for;
  coordination and preparation of regulatory submissions in Europe for new chemical entities,
  Authorisation to conduct clinical trials in Europe,
  Reporting of adverse events from products in clinical development and marketed products.

• Regulatory Scientist

  Marion Merrell Dow Research Institute

  (Pharmaceuticals industry)

  June 1988 — June 1989 (1 year 1 month)

  Responsible for obtaining authorisation to conduct clinical trials in European countries and responsible for reporting of adverse events to regulatory agencies in Europe for research and marketed products.

• Product Registration Manager

  Tate & Lyle

  (Public Company; Food Production industry)

  September 1984 — June 1988 (3 years 10 months)

  Reponsible for the safety evaluation of novel food additives. Involving the development and management of safety programmes to support the marketing of new food additives. Responsible for the registration of food additives in Europe and the USA.

• Post Doctoral Research Fellow

  St Mary's Hospital Medical School

  (Higher Education industry)

  September 1983 — July 1984 (11 months)

  Academic teaching and research post. Research in drug metabolism and pharmacokinetics, particularly of food flavours. Supervision of medical and post graduate students. Various Scientific papers given and published on postgraduate work.

• Post Graduate Student

  St Mary's Hospital Medical School

  (Pharmaceuticals industry)

  September 1980 — September 1983 (3 years 1 month)

  Thesis: The metabolism and disposition of trans-anethole and p-propylanisole in rodent species and man.

• Research Biochemist

  Wyeth Research

  (Public Company; WYE; Pharmaceuticals industry)

  July 1978 — September 1980 (2 years 3 months)

Susan Sangster’s Education

• University of London

  PhD , Biochemistry , 1981 — 1983

  Thesis The metabolism and disposition of trans-anethole and p-propylanisole in rodent species and man.
  
  10 publications linked to research

• University of Surrey

  BSc , Medical Biochemistry , 1974 — 1978

  One year spent in industry;
  National Vegetable Research Centre, Wellesbourne, Warwickshire, UK
  Publication: Annals of Applied Biology Vol 89,pp257-264

  Activities and Societies:

  First eleven hockey team member

Additional Information

Susan Sangster’s Interests:

Outdoor activities; skiing, sailing, surfing and hiking. Ex-hockey player. Professional training in regulatory affairs

Susan Sangster’s Groups:

Member of British Biochemical Society, Fellow of The Organisation for Professionals in Regulatory Affairs, Past member of various Professional(Governing Body and Education Committee of TOPRA) and Trade association committees(EFPIA and Interpharma) on behalf of employers

Susan Sangster’s Honors:

Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA)

Susan Sangster’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch